Endochoice, Inc.: FDA filings under this applicant name
FDA lists 27 510(k) clearances under the applicant name “Endochoice, Inc.” (first 2010, latest 2016), across 14 product codes in 2 review panels. Median 510(k) review time under this name: 109 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Boston Scientific, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 196 |
| 2013 | 5 | 106 |
| 2014 | 7 | 109 |
| 2015 | 3 | 127 |
| 2016 | 6 | 84 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FEQ | Pump, Air, Non-Manual, For Endoscope | 6 | 6 |
| OCX | Endoscopic Irrigation/Suction System | 4 | 4 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 2 | 2 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | 2 |
| FDI | Snare, Flexible | 2 | 2 |
| FDS | Gastroscope And Accessories, Flexible/Rigid | 2 | 2 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 2 | 2 |
| ESW | Prosthesis, Esophageal | 1 | 1 |
| JCT | Prosthesis, Tracheal, Expandable | 1 | 1 |
| KGE | Forceps, Biopsy, Electric | 1 | 1 |
Plus 4 more product codes.
Review panels
Most recent Endochoice, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K160275 | Fuse Endoscopic System with FuseBox Processor | PEA | 2016-08-01 | 181 |
| K161482 | EndoChoice Water Bottle Cap Irrigation System | FEQ | 2016-06-27 | 27 |
| K161167 | Seal Single-Use Biopsy Valve | OCX | 2016-05-26 | 30 |
| K160403 | SmartStart Air/Water and Suction Valves | ODC | 2016-05-19 | 97 |
| K153588 | EndoChoice Water Bottle Cap System | FEQ | 2016-02-24 | 70 |
| K151475 | EndoChoice Select Injection Needle | FBK | 2016-02-08 | 251 |
| K152182 | Fuse Gastroscopy System | FDS | 2015-12-10 | 127 |
| K152580 | rescuenet | FDI | 2015-11-03 | 54 |
| K142155 | ENDOCHOICE WATER BOTTLE CAP SYSTEM | FEQ | 2015-01-20 | 167 |
| K140472 | BONASTENT TRACHEAL / BRONCHIAL | JCT | 2014-10-17 | 234 |
17 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2015-12-18.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Endochoice, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02651857: Exploratory Study of Upper and Lower Endoscopic Fuse System (Completed, started 2015-11)
Frequently asked questions
How many FDA 510(k) clearances are listed under Endochoice, Inc.?
FDA lists 27 510(k) clearances under the applicant name “Endochoice, Inc.” (first 2010, latest 2016), across 14 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Endochoice, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Endochoice, Inc. is 109 days.
Which FDA product codes appear under Endochoice, Inc.?
The most frequent FDA product codes under this applicant name are FEQ (Pump, Air, Non-Manual, For Endoscope, 6); OCX (Endoscopic Irrigation/Suction System, 4); FBK (Endoscopic Injection Needle, Gastroenterology-Urology, 2).
Next steps
- See all 27 Endochoice, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FEQ, Endochoice, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.